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Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for shortor long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The subject Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-thewire. The subject devices are minimally tapered 5.0 Fr single and double lumen catheters. The set components may include the PICC. obturator. Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

The provided text (K132883) describes the testing and acceptance criteria for the "Turbo-Ject® Peripherally Inserted Central Venous Catheter Set". This is a medical device, and the testing described here relates to its mechanical performance and safety, not an AI/ML-driven diagnostic or image analysis device. As such, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set ground truth) are not applicable to this type of device and study.

However, I can extract the relevant information regarding the acceptance criteria and the performance studies as described in the document.

Summary of Device Acceptance Criteria and Performance Study for a Medical Device (Turbo-Ject® PICC Set):

The device is a non-AI/ML medical device (a catheter set). The acceptance criteria and testing focus on physical and mechanical performance to ensure safety and effectiveness, not diagnostic accuracy or human-AI interaction.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not specify the exact sample sizes (number of units tested) for each mechanical test.
• The data provenance is not explicitly stated in terms of country of origin for the data or whether it was retrospective or prospective. These are typically laboratory-based engineering tests conducted by the manufacturer (Cook Incorporated, U.S.A.).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is a mechanical device, not one requiring expert human interpretation for ground truth. Ground truth for these tests is established by physical measurement and engineering standards (e.g., ISO standards, pressure gauges, leakage detection methods).

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, these are objective mechanical tests, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a catheter set, and its performance is assessed through laboratory mechanical testing.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device, not an algorithm. The "standalone" performance is the mechanical test results themselves.

7. The Type of Ground Truth Used:

• The ground truth for these tests is based on engineering standards, physical measurements, and objective pass/fail criteria derived from the device's intended physical performance and safety requirements (e.g., a certain tensile strength, absence of leakage, ability to withstand pressure).

8. The Sample Size for the Training Set:

• Not Applicable. This device development did not involve a "training set" in the context of machine learning. The design and manufacturing process would involve internal development and validation, but not a distinct machine learning training set.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

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Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The proposed Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr single and double lumen catheters. A taper is a design element meant to help "wedge" the catheter into the tract by having a transition from a larger Fr size to the labeled Fr size. The proposed minimal taper design provides the same wedge feature only a △1 Fr versus Δ2 Fr from the manifold to the labeled Fr size of the catheter. The primary advantage of the 1 Fr size minimal taper is ease of insertion.

The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide and other convenience components. The set is supplied sterile and is intended for one-time use.

This document describes the 510(k) summary for the Cook Turbo-Ject® Peripherally Inserted Central Venous Catheter Set (K132334). The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K072625) through design modifications and performance testing, rather than a clinical study involving human readers or extensive ground truth establishment.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing to support substantial equivalence. The "acceptance criteria" are implied by conformance to standards and successful test outcomes.

2. Sample Size Used for the Test Set and the Data Provenance

The document primarily describes bench testing for physical and mechanical properties of the device.

• Sample Size: The document does not specify the exact number of units or samples used for each test (e.g., how many catheters were tested for tensile strength).
• Data Provenance: The data provenance is from laboratory bench testing of the manufactured device. There is no information regarding country of origin for data or whether it's retrospective or prospective, as this is laboratory testing, not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission relies on engineering and laboratory performance testing, not expert-adjudicated clinical data requiring ground truth establishment by healthcare professionals for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing of physical properties, there is no adjudication method in the context of clinical interpretation or diagnostic performance. Test results are objective measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a submission for a medical device (PICC catheter), not an artificial intelligence (AI) or imaging diagnostic device. Therefore, no MRMC study or AI-assisted assessment of human readers was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device; there is no algorithm or standalone performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described would be the physical and mechanical properties of the catheter as measured in a controlled laboratory environment against established engineering and international performance standards (e.g., ISO 10555-1:1995).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The Turbo-Ject® PICC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject® PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Turbo-Ject® PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The Turbo-Ject® PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-the-wire. The currently marketed Turbo-Ject® PICCs are available in the following configurations: 4.0 Fr single lumen, 5.0 Fr single lumen, and 5.0 Fr double lumen. The currently marketed Spectrum® Turbo-Ject® PICCs are available in the following antimicrobial agent impregnated configurations: 3.0 Fr single lumen, 4.0 Fr single lumen, 5.0 Fr single lumen, 5.0 Fr double lumen, and 6.0 Fr triple lumen. The proposed devices add two additional non-impregnated configurations, a 3.0 Fr single lumen catheter and a 6.0 Fr triple lumen catheter.

The provided text describes a Special 510(k) submission for a device modification, not a study evaluating an AI device or algorithm. Therefore, many of the requested categories (such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and data provenance) are not applicable to this document.

The document focuses on demonstrating substantial equivalence for modifications to existing Peripherally Inserted Central Venous Catheters (PICCs) by Cook Incorporated. The "acceptance criteria" discussed are for the physical and functional performance of the medical device itself, not for the performance of an AI algorithm.

Here's a summary of the information that can be extracted relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Flow Rates: The document also specifies performance for maximum flow rates and injection pressure limits, which are part of the device's functional performance:

Information Not Applicable to this Document (as it's not an AI/algorithm study):

2. Sample size used for the test set and the data provenance: Not applicable. This document describes physical device testing, not data-driven algorithm validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is typically based on engineering standards and measurements, not expert consensus on images/data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" for the tests mentioned (Static Failure Pressure, Flow Rate, Tensile Strength, Biocompatibility) would be established by validated engineering tests and adherence to international standards (e.g., BS EN ISO 10555-1:2009 for tensile strength, BS EN ISO 10993-1:2009 for biocompatibility).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Turbo-Ject Peripherally Inserted Central Venous Catheters (PICC) are indicated for short or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rated indicated, as shown on the following table.

| Catheter Size | Maximum Flow Rate* | Injection Pressure
Limit Setting |
|-------------------|--------------------|-------------------------------------|
| 4 Fr Single Lumen | 4 ml/sec | 325 psi |
| 4 Fr Double Lumen | 3 ml/sec | 325 psi |
| 5 Fr Single Lumen | 7 ml/sec | 325 psi |
| 5 Fr Double Lumen | 5 ml/sec | 325 psi |

*Flow rates achieved using room temperature Omnipaque 3000 contrast and veriffed using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.

The Turbo-Ject PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters for short or long-term use. The Turbo-Ject PICC catheters are 60 cm in length and available in 4 and 5 Fr single lumen and 4 and 5 Fr double lumen.

The set components include an introducer needle, wire guide, locking Peel-Away sheath introducer, 12cc syringe and hydrophilic-coated wire guide obturator for non-over-thewire versions. The tray components include all set items in addition to 22 and 25 gauge needles, lidocaine, antiseptic sponges, drape, gauze, 3 cc syringe, suture with needle and needle holder. The set components will be the same for the single and double lumen Turbo-Ject PICC catheter.

The provided text describes acceptance criteria and testing for the Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC). However, it does not contain information about a study proving the device meets the acceptance criteria in the context of an AI/ML device, as requested in the prompt. The device described is a physical medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies cannot be addressed from the given document.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

Acceptance Criteria and Device Performance (as much as can be derived for a physical device):

Since the device described is a physical medical device and not an AI/ML algorithm, the following sections cannot be answered from the provided document as they pertain to AI/ML device studies:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical medical device. The document mentions tests but not a "test set" in the context of data for an algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for an AI/ML algorithm is not relevant for the physical performance tests of a catheter.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This relates to AI/ML performance compared to human performance, which is not relevant for a catheter's physical properties.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device's performance is adherence to engineering specifications and safety standards, validated through physical testing.
7. The sample size for the training set: Not applicable. No training set for an AI model.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the safety and performance testing for a physical medical device (Turbo-Ject PICC Catheter) to demonstrate its substantial equivalence to predicate devices, rather than an AI/ML diagnostic or therapeutic device.

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